Quality Assurance Specialist – Compliance & Documentation

Medline; Chicago (IL); On-site; USD 67,000 - 101,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Continuing education

Job summary

Medline is seeking a Quality Assurance professional in Illinois to specialize in areas of the Quality Management System such as device master records, customer complaints, and recalls. Responsibilities include documenting and maintaining quality processes, analyzing specifications, tolerances, and testing reports, and supporting ERP data analysis.

The role requires a Bachelor's degree in Engineering/Science/Math or related field and at least 2 years in quality, with strong MS Office and

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field is required.
• At least 2 years of experience in Quality.
• Strong MS Office skills and ability to analyze documentation.
• Working knowledge of government and industry quality assurance standards (e.g. 21 CFR 820, ISO 13485).

Responsibilities

• Assist in developing and implementing processes, reports, data analysis and procedures within the defined area of specialization.
• Collaborate with internal and external groups to ensure compliance with FDA, ISO and internal requirements.
• Facilitate meetings with global units, sales, marketing, and branch personnel to manage project requirements and deadlines.
• Track and report progress to management.
• Review related documentation for completeness and accuracy to meet specifications.
• Make recommendations based on documentation and analysis to improve quality standards and customer experience.

Skills

Quality systems

Time management

MS Office

Documentation analysis

FDA/ISO knowledge

Problem solving

Education

Bachelor’s degree in Engineering, Science, Math or related field

Tools

MS Office Suite

ERP system

Job description

Medline is seeking a Quality Assurance professional in Illinois to specialize in areas of the Quality Management System such as device master records, customer complaints, and recalls. Responsibilities include documenting and maintaining quality processes, analyzing specifications, tolerances, and testing reports, and supporting ERP data analysis.

The role requires a Bachelor's degree in Engineering/Science/Math or related field and at least 2 years in quality, with strong MS Office and